Home NDC 0832-8304 Isotretinoin
Product NDC 0832-8304
11-digit product format 008328304
Labeler code 0832
Product ID 0832-8304_4abc427d-939a-2bc9-e063-6294a90ae582
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isotretinoin
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA076485
Marketing category ANDA
Marketing start 2012-05-01
Substance ISOTRETINOIN
Active strength 40 mg/1
Pharmacologic classes Retinoid [EPC], Retinoids [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076485-001 MYORISAN ISOTRETINOIN 10MG CAPSULE / ORAL AB1 2012-01-19 A076485-002 MYORISAN ISOTRETINOIN 20MG CAPSULE / ORAL AB1 2012-01-19 A076485-003 MYORISAN ISOTRETINOIN 40MG CAPSULE / ORAL AB1 2012-01-19 A076485-004 MYORISAN ISOTRETINOIN 30MG CAPSULE / ORAL AB1 2015-08-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 5 · 164 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076485-001 MYORISAN 10MG CAPSULE / ORAL AB1 2012-01-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076485-002 MYORISAN 20MG CAPSULE / ORAL AB1 2012-01-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076485-003 MYORISAN 40MG CAPSULE / ORAL AB1 2012-01-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076485-004 MYORISAN 30MG CAPSULE / ORAL AB1 2015-08-25 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Isotretinoin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOTRETINOIN 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination EH28UP18IF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197843 Internal RxNorm lookup 197844 Internal RxNorm lookup 197845 Internal RxNorm lookup 403930 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0832-8304-30 Isotretinoin 3 in 1 BOX CAPSULE, LIQUID FILLED 3 3 0832-8304-89 Isotretinoin 10 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0832-8304 ISOTRETINOIN CAPSULE, LIQUID FILLED [UPSHER-SMITH LABORATORIES, LLC] 1 Current NDC, 2 package rows 20230610_c369e1c3-90c5-4768-9741-56c62253a2c4.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0832-8304-30 00832830430 3 BLISTER PACK in 1 BOX (0832-8304-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0832-8304-89) 3 blister pack 2023-06-06 No No Current 0832-8304-89 00832830489 10 in 1 BLISTER PACK Historical